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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Prospect Enterprise, Inc. 13-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070

Telephone: 510-337-6700

VIA FEDERAL, EXPRESS

July 13, 2001

Our Reference: 2924080

Central Fish Company
Ernest H. Doizaki, President
Prospect Enterprise, Inc.
550 Ceres Avenue
Los Angeles, California 90013

WARNING LETTER

Dear Mr. Doizaki:

On May 21 and 23,2001, we inspected your seafood processing plant, Central Fish Company, located at 1535 Kern Street, Fresno, California. We conducted the inspection to determine your compliance with FDA?s Seafood HACCP regulations, 21 Code of Federal Regulations (21 CFR 123) and the Good Manufacturing Practice (GMP) requirements for foods (21 CFR 110).

We found that your firm has serious HACCP and GMP deviations. These deviations cause your seafood products to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that the fish have been prepared, packed, or held under insanitary conditions, whereby they maybe rendered injurious to health. We listed the deviations on a Form FDA 483 (Inspectional Observations) and discussed them with Ms. Lydia E. Doizaki, General Manager, at the conclusion of the inspection. We are enclosing a copy of the FDA 483 for your reference. The deviations are as follows:

  1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with21 CFR 123.6(b).

(a) However, your firm does not have a HACCP plan for scombroid species such as tuna, Mahi-mahi, and Escolar, to control the food safety hazard of histamine formation as a result of time/temperature abuse.

(b) However, your firm does not have a HACCP plan for Sushi tuna and mackerel to control the food safety hazards of histamine formation and pathogens.

(c) However, your firm does not have a HACCP plan for refrigerated ready-to-eat seafood products such as shrimp, octopus, and smoked salmon to control the food safety hazard of pathogens.

2. You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for imported seafood from [redacted] such as rockfish, petrale, and halibut fillets.

3. You must adequately monitor and document sanitation conditions and practices, to comply with 21 CFR 123.11(b) and (c). However, your firm did not monitor the following areas of sanitation to ensure control:

a) Condition and cleanliness contact surfaces of food ? Inadequately cleaned equipment and utensils;

b) Prevention of cross-contamination ? Employees were observed handling different food products such as raw fish, cooked octopus, raw shrimp, cleaning food contact surfaces, taking out trash and not washing their hands in between each process. A dirty fm was also observed blowing directly over the fish processing table. Pallets of seafood were being wheeled through standing water in the receiving storage room;

c) Maintenance of hand washing and hand sanitizing facilities ? Lack of running water in one of the sinks, and lack of hand towels in the processing area;

d) Protection of food and food contact surfaces from adulterants ? Employees were observed using metal scrubs to clean cutting boards and knives, leaving metal fragments on the food processing table. Two lighting fixtures located directly above the fish processing table lacked protective covering;

e) Exclusion of pests from the processing area ? Numerous flies were observed in the processing room where exposed fish were being cut, filleted, cleaned, and packaged. A gap (approximately ? inch) was also observed under the southwest door allowing the entry of flies into the receiving/storage room.

We may take further regulatory action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You may wish to include in your response documentation such as time/temperature monitoring records, sanitation records, HACCP plans, etc. If you cannot complete all the corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deficiencies.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your seafood firm operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.

Sincerely,

/s/

Dennis K. Linsley

Director

San Francisco District